PROLYTE ELECTROLYTE ANALYZER

Electrode, Ion Specific, Sodium

DIAMOND DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Diamond Diagnostics, Inc. with the FDA for Prolyte Electrolyte Analyzer.

Pre-market Notification Details

Device IDK070104
510k NumberK070104
Device Name:PROLYTE ELECTROLYTE ANALYZER
ClassificationElectrode, Ion Specific, Sodium
Applicant DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. Holliston,  MA  01746
ContactRandolph Quinn
CorrespondentRandolph Quinn
DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. Holliston,  MA  01746
Product CodeJGS  
Subsequent Product CodeCEM
Subsequent Product CodeCGZ
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-10
Decision Date2008-05-07
Summary:summary

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